Regulatory Focus™ > News Articles > 2 > First US System to Produce Medical Isotope Used in Diagnostic Imaging Wins FDA Approval

First US System to Produce Medical Isotope Used in Diagnostic Imaging Wins FDA Approval

Posted 08 February 2018 | By Zachary Brennan 

First US System to Produce Medical Isotope Used in Diagnostic Imaging Wins FDA Approval

The US Food and Drug Administration (FDA) on Thursday approved Wisconsin-based NorthStar Medical Radioisotopes’ RadioGenix System, the first non-uranium-based process for producing Technetium-99m (Tc-99m), which is the most widely used radioisotope in medical imaging.

According to FDA, Tc-99m is a diagnostic agent that is used by health care professionals with imaging devices to detect diseases like coronary artery disease and cancer, in addition to evaluating lung, liver, kidney and brain function.

“Every day, tens of thousands of people in the US undergo a nuclear medical imaging procedure that depends on Tc-99m,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “Today’s approval has been the result of years of coordination across the FDA and with US government organizations and marks the first domestic supply of Mo-99 – the source of Tc-99m –  in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine.”

Peter Hanlon, assistant deputy administrator of the Office of Material Management and Minimization of the National Nuclear Security Administration in the Department of Energy, said NorthStar will build up from meeting 10% of US demand to eventually supplying about two-thirds of what the US needs.


Prior to Thursday’s approval, Molybdenum-99 (Mo-99), the parent of Tc-99m, could only be produced from enriched uranium by several facilities outside the US, leaving the country vulnerable to shortages or supply chain issues.

To address these challenges, Congress enacted the American Medical Isotopes Production Act of 2012, with provisions to eliminate the use of highly enriched uranium for medical isotope production and encouraged the development of domestic supplies.

Federal agencies – including FDA, NRC and the Department of Energy’s National Nuclear Security Administration and National Laboratories, among others – have been working with industry for about five years to develop new technology that helps to minimize the industry’s dependence on highly enriched uranium from outside the US.

Louis Marzella, director of the Division of Medical Imaging Products at FDA’s CDER, explained that the US government put a premium on moving away from the use of highly enriched uranium because of concerns about diversion.

NorthStar Medical Radioisotopes has received $50 million in federal grants, according to a New York Times article that also discussed another Wisconsin-based company racing to win approval for its Mo-99.

In addition to the approval, the Nuclear Regulatory Commission (NRC) is issuing guidance and will license the RadioGenix System to enable the Tc-99m it produces to be used for its medical purpose.

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.